BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V 2.0 FIRM EXT PEBAX

    MDR report key: 2990776 · Received March 5, 2013

    Report

    Report Number
    0002954917-2013-00030
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    August 19, 2012
    Report Date
    March 1, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K082034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, EMBOLUS IS NOTED IN THE DIRECTION FOR USE (DFU). THEREFORE, THE PROBABLE CAUSE OF THE EVENT IS ANTICIPATED PROCEDURAL COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE TO REMOVE A CLOT FROM THE LEFT MIDDLE CEREBRAL ARTERY, AN OBSTRUCTION OF THE LEFT ANTERIOR CEREBRAL ARTERY WAS NOTED. TISSUE PLASMOGEN ACTIVATOR (T-PA) WAS NOT ADMINISTERED DUE TO TIME FACTORS. NO MEDICAL INTERVENTION WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE TO REMOVE A CLOT FROM THE LEFT MIDDLE CEREBRAL ARTERY, AN OBSTRUCTION OF THE LEFT ANTERIOR CEREBRAL ARTERY WAS NOTED. TISSUE PLASMOGEN ACTIVATOR (T-PA) WAS NOT ADMINISTERED DUE TO TIME FACTORS. NO MEDICAL INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93649 V 2.0 FIRM EXT PEBAX CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other